(131 days)
The LensHooke CA0 Sperm Separation Device and the LensHooke CA1 Sperm Separation Device are intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.
The LensHooke CA0 Sperm Separation Device and LensHooke CA1 Sperm Separation Device are used to prepare motile sperm from semen based on the mobility of motile sperm. The LensHooke Sperm Separation Device has a base and filter layers to separate and process the semen sample. The LensHooke Sperm Separation Device has two models, CA0 with one filter layer and CA1 with two filter layers. Liquefied semen (1 mL) is added to the base and sperm washing medium is added to the filter via a filter port. After incubation, the separated sperm are collected from the filter layer via the filter port. The subject devices are radiation-sterilized with a sterility assurance level (SAL) of 10 °. The LensHooke Sperm Separation Devices are individually packaged and for single-use only.
The device in question is the LensHooke CA0 Sperm Separation Device and the LensHooke CA1 Sperm Separation Device.
Here's a breakdown of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Human Sperm Survival Assay (HSSA): ≥80% of the control motility at 24 hours after exposure for 30 minutes. | The HSSA was performed before and after accelerated aging to support a 2-year shelf life. The rate of motile sperm after incubation was compared to that of a control (no exposure to the subject device). The device met this criterion. |
| Endotoxin: ≤20 EU/device | The device demonstrated levels of endotoxin below or equal to 20 EU/device, as confirmed by USP and ANSI/AAMI ST72:2019 testing. |
| Sterility: 10⁻⁶ SAL (Sterility Assurance Level) | The device underwent Sterilization Validation Study per ISO 11137-1:2006, confirming a sterility assurance level of 10⁻⁶. |
| Package Integrity (Seal Strength): Met requirements of ASTM F88/F88M-15 | Package integrity testing following accelerated aging per ASTM F1980-21 included Seal strength testing Per ASTM F88/F88M-15. The device met this criterion. |
| Package Integrity (Dye Penetration): Met requirements of ASTM F1929-15 | Package integrity testing following accelerated aging per ASTM F1980-21 included Dye penetration testing per ASTM F1929-15. The device met this criterion. |
| Transportation Simulation: Met requirements of ISTA 3A (2018) | A Transportation Simulation Study per ISTA 3A (2018) was conducted to ensure the device's integrity during transport. The device met this criterion. |
| Sperm Separation Performance (Motility Improvement): Improvement in percentage of motile sperm and progressively motile sperm in output samples compared to input samples. | CA0 device: Average improvement in total motility of 24.4% and an average improvement in progressive motility of 26.6%. |
| CA1 device: Average improvement in total motility of 25.9% and an average improvement in progressive motility of 27.1%. | |
| Note: Specific quantitative acceptance criteria for motility improvement were not explicitly stated in the provided text, but the reported improvements demonstrate effective performance. | |
| Shelf-Life: 24 months | Supported by package integrity and HSSA testing after accelerated aging. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the numerical sample size for the "test set" in terms of number of donor semen samples used for the Human Sperm Survival Assay (HSSA) or the Sperm Separation Performance study. It mentions using "donor sperm" and "donor semen samples" without specifying the quantity.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The studies described are primarily benchtop or laboratory performance tests, not clinical studies involving expert interpretation of results to establish ground truth in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set:
This information is not applicable as the studies are technical performance tests and not clinical studies requiring expert adjudication of case interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The studies described are focused on the device's technical performance in isolating motile sperm and maintaining sperm viability, not on comparing reader effectiveness with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the studies described are standalone performance evaluations of the device (LensHooke CA0/CA1 Sperm Separation Device) without human-in-the-loop performance considerations. The device is a physical product designed for sperm separation, not an AI algorithm.
7. The Type of Ground Truth Used:
The ground truth for the performance studies was established through:
- Laboratory measurements and assays: For HSSA, this involves measuring sperm motility percentage using established laboratory methods. For endotoxin, it's quantitative measurement against a standard. For sterility, it's confirmation of a specific SAL.
- Comparison to control samples: In the HSSA, the motility of sperm exposed to the device was compared to that of a control group (sperm not exposed to the device).
- Direct measurement of output characteristics: For sperm separation performance, the percentage of motile and progressively motile sperm in the output samples was directly measured and compared to the input samples.
- Industry standards and specifications: For physical tests like package integrity and transportation simulation, the ground truth is adherence to the specified ASTM and ISTA standards.
8. The Sample Size for the Training Set:
This information is not applicable. The LensHooke CA0/CA1 Sperm Separation Device is a physical medical device, not an AI/machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the device is not an AI/machine learning algorithm requiring a training set.
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.